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Oxfordshire Women and Their Children's Health (OxWATCH)

10. maj 2018 opdateret af: Ingrid Granne, Oxford University Hospitals NHS Trust

Oxfordshire Women and Their Children's Health- A Feasibility Study

The aim of this feasibility study is to test recruitment of participants into Phase 1 of the study and then the re-recruitment and retention of participants in Phase 2 of the study. The investigators will also be assessing the acceptability of recruitment strategy and data collection to participants.

The effect of pre-pregnancy factors (biophysical, genetic, socioeconomic, behavioural and psychological) on obstetric, cardiovascular, socioeconomic, behavioural and psychological outcomes will all be examined.

Studieoversigt

Detaljeret beskrivelse

The aim of this study is to recruit 300 women. The investigators anticipate that a subset of recruits will become pregnant during the pilot study.

This is a feasibility study with two phases:

  • Phase 1: A detailed characterisation of nulliparous women who have an address in Oxfordshire or work in Oxfordshire
  • Phase 2: Detailed assessment of events during and immediately after a first viable pregnancy.

During the Phase 1 visit:

  • Participation is explained by a research nurse/midwife, any questions are answered and women, who agree, sign the consent form.
  • A questionnaire covering medical and family history, socioeconomic information, behavioural factors and psychological measures will be completed.
  • Baseline anthropometry - height, weight, hip/ waist ratio, USS measurement of fat (thigh and abdomen), bioimpedence.
  • Cardiovascular - pulse and BP (peripheral / central), arterial stiffness, echocardiogram, carotid imaging and endothelial function (endo-check) tests are completed.
  • Fasting venous blood sample (maximum 40 mls) including whole blood for maternal DNA.
  • Urine sample
  • Salivette

Once a participant has become pregnant she is eligible to enter phase 2 of the study. Phase 2 involves 6 further visits at 7, 11-13, 18-20, 28, 34 weeks gestation and 3 months post-delivery. During these visits repeated measurements of the above investigations will be carried out.

In addition, there will be a fetal ultrasound at 7 and 28 weeks and questionnaires at 7, 28 and 3 months post-delivery. An acceptability questionnaire will also be given to participants following completion of the study.

The end of the feasibility study will be the date of the final phase 2 visit of the last participant becoming pregnant during the feasibility study.

By collecting the above data the investigators anticipate recording and reporting longitudinal data in relation to the following:

•Incidence of obstetric complications

The incidence of pre-eclampsia, gestational diabetes, pregnancy induced hypertension, antenatal and postnatal depression and preterm birth.

•Longitudinal variation in cardiovascular parameters

Changes in longitudinal measures of blood pressure, carotid intima media thickness, pulse wave velocity, cardiac structure and function and endothelial function from pre-conception until 34 weeks gestation.

•Longitudinal changes in socioeconomic factors

By use of a questionnaire at pre-conception, 7 weeks gestation and 28 weeks gestation we will record employment and relationship status.

•Longitudinal changes in behavioural factors

By use of a questionnaire at pre-conception, 7 weeks gestation and 28 weeks gestation the investigators will record diet, weight control and perception, exercise, smoking, alcohol use and drug use.

•Longitudinal changes in psychological factors

By use of a questionnaire at pre-conception, 7 weeks gestation and 28 weeks gestation the investigators will record levels of anxiety, depression and quality of life and perceived health status.

•Longitudinal changes in the health status of participant and their family

By use of a questionnaire at pre-conception the investigators will record the participants' medical and family history, reproductive and sexual history and pain perception. At 7 weeks gestation and 28 weeks gestation the questionnaire will enquire about any changes or additions to the participants' medical and family history as well as reproductive and sexual health and pain perception.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

250

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Participants will be nulliparous women of reproductive age (18-40 years), who are not pregnant but could have a planned or unplanned pregnancy during the duration of the study. Participants must be willing to have research investigations before, during and after pregnancy.

Beskrivelse

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study
  • Participant is female, aged 18-40 years
  • Participant is not pregnant
  • Participant lives or works in Oxfordshire

Exclusion Criteria:

  • A previous live birth or still birth after 24 weeks gestation

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Feasibility Study
Nulliparous women of reproductive age (18-40 years), who are not pregnant but could have a planned or unplanned pregnancy during the duration of the study.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Recruitment feasibility
Tidsramme: 2 years
This will be measured by the number of participants recruited into Phase 1 (pre-pregnancy) and Phase 2 (pregnancy) of the study. The investigators intend to recruit 300 participants into Phase 1 and 100 participants into Phase 2.
2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Levende fødselsrate
Tidsramme: 2 år
2 år
The retention of participants in Phase 2
Tidsramme: 2 years
The investigators aim to retain 90% of participants recruited into Phase 2 from 7 weeks gestation until delivery.
2 years
Incidence of pregnancy within 12 months of recruitment.
Tidsramme: 2 years in total, 12 month for each recruit
2 years in total, 12 month for each recruit
Incidence of miscarriage and ectopic pregnancy in Phase 2 participants
Tidsramme: 2 years
2 years
Incidence of loss to follow-up
Tidsramme: 2 years
2 years
Proportion of participants who provide full data at baseline and throughout pregnancy
Tidsramme: 2 years
2 years
Acceptability of the recruitment strategy to participants
Tidsramme: 2 years
At the end of a participant's involvement in the study the participant will be asked to complete an anonymous, validated acceptability questionnaire. It is anticipated that this will provide insight into why participants took part, the acceptability of the recruitment strategy, the participant's reactions to research participation and how acceptable the participant found study requirements and assessments.
2 years
Acceptability of the data collection procedures to participants.
Tidsramme: 2 years
At the end of a participant's involvement in the study the participant will be asked to complete an anonymous, validated acceptability questionnaire. It is anticipated that this will provide insight into why participants took part, the acceptability of the recruitment strategy, the participant's reactions to research participation and how acceptable the participant found study requirements and assessments.
2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Efterforskere

  • Ledende efterforsker: Ingrid Granne, University of Oxford

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. april 2013

Primær færdiggørelse (Forventet)

31. december 2018

Studieafslutning (Forventet)

31. december 2018

Datoer for studieregistrering

Først indsendt

20. januar 2015

Først indsendt, der opfyldte QC-kriterier

14. april 2015

Først opslået (Skøn)

17. april 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. maj 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. maj 2018

Sidst verificeret

1. maj 2018

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

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UBESLUTET

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